Balloon occlusion device having a proximal valve

ABSTRACT

A medical device for vessel occlusion, the medical device including an elongated body having a distal end portion, a proximal end portion, and a lumen disposed therethrough, an balloon disposed at the distal end portion of the elongated body, the balloon in fluid communication with the lumen. An opening defined at the proximal end portion of the elongated body, the opening being in fluid communication with the balloon via the lumen, and a valve body moveably disposed at the proximal end portion of the elongated body, the valve body movable between a closed position and an open position, the valve body configured to engage a surface of the elongated body, distal to the opening, to seal the opening when the valve body is in the closed position.

CLAIM OF PRIORITY

The present application claims priority under 35 U.S.C. § 119 to U.S.Provisional Application Ser. No. 60/212,187 filed on Jun. 16, 2000,entitled “Angioplasty Catheter”, the entirety of which is incorporatedby reference herewith.

1. FIELD OF THE INVENTION

The present invention relates to medical devices, specifically a medicaldevice having a low profile valve for selectively inflating anddeflating an inflatable balloon disposed upon the medical device,wherein the valve allows passage of interventional devices over themedical device during use.

2. BACKGROUND OF THE INVENTION

In order to perform many vascular procedures a guidewire is initiallyinserted into the patient's vasculature. The guidewire is generallyinserted into the patient through an incision created in the patient'sfemoral artery. After the guidewire has been placed within the patient'svasculature, other interventional devices such as catheters may bepassed over the guidewire. As used herein, the term “interventionaldevice” is intended to include, but not be limited to, any known devicecapable of being inserted within the human vasculature for diagnosis,treatment or inspection thereof. Additionally the terms “catheter” and“guidewire” as utilized herein are intended to be interchangeable whenreferring to the medical device in accordance with the presentinvention.

One difficulty associated with this procedure however is that theguidewire must be held in place while the interventional device ispassed over the guidewire. It is possible that the guidewire may becomedislodged from the position where it was initially placed, thereforewhen a interventional device is advanced over the guidewire it may notbe advanced to the desired position.

A common medical procedure where it is desirable to place a guidewireand then advance interventional devices over the guidewire areangioplasty and/or bypass procedures. In an angioplasty procedure, theguidewire may be advanced up to or through a blockage in a patient'svessel, wherein a catheter containing a stent or other interventionaldevice is then passed over the guidewire to the occluded area.

A common procedure performed on occluded or narrowed vessels is to placean angioplasty catheter having a balloon disposed on one end within theoccluded region and expanding the balloon, thereby expanding the vessel.The balloon catheter is typically formed of a flexible material whereinthe catheter includes radiopaque markings thereon in order to properlyplace the balloon within the desired region. The balloon catheter isplaced within the patient's vasculature through a percutaneous accesssite such as the femoral artery. The balloon catheter is placed withinthe patient's vasculature by tracking the catheter over a guidewirewhich has been placed first. The guidewire enables a user to more easilytrack the flexible catheter into a proper position, wherein the balloonmay be inflated to expand the vessel and/or occlusion therein.

Another commonly utilized cardiovascular procedure is stenting. Stentingis a procedure wherein a expanding device is placed within an obstructedvessel in order to hold open or expand the constricted vessel. Stentingprocedures are carried out in a manner similar to the balloonangioplasty procedure described above. Many times both procedures willbe performed wherein the vessel may be first expanded with a ballooncatheter and subsequently a stent will be deployed thereafter tomaintain the expanded diameter of the vessel.

During stenting and/or balloon angioplasty procedures there is the riskthat plaque or other debris may be dislodged from the inner walls of thevessel. The plaque may be in the form of small particles which may becarried within the patient's blood stream and may lead to othercomplications such as embolism if the particles become lodged into abranch vessel or artery and restrict or prevent blood flow to thatvessel or artery.

Therefore it is desirable to provide a device which may be utilizedduring a medical procedure such as those described above wherein thedevice may be utilized to prevent dislodged particles from flowing intoa patient's blood stream and potentially causing further blockage or astroke. It is also desirable to provide a device which may be utilizedto temporarily occlude a vessel distal an area where a surgicalprocedure is to be performed thereby providing a contained area for thesurgeon to operate within.

One such device has been disclosed in U.S. Pat. No. 5,807,330 toTeitelbaum, the entirety of which is incorporated by reference herewith.However, there remains a desire for an improved low profile valve forthe device of Teitelbaum.

A further object of the present invention therefore is to provide amedical device having a low profile valve means disposed on the proximalend portion, wherein the valve may be selectively opened and closedthereby enabling the inflation and deflation of a balloon disposed atthe distal end portion of the device. Furthermore, the valve provides asufficiently low profile area wherein other interventional devices maybe passed over the medical device to conduct surgical procedures withinthe patient's vasculature.

A further object of the present invention is to provide an medicaldevice wherein an balloon disposed upon the distal end portion of thedevice may be selectively inflated or deflated through a valve meanswherein the inflation device is removable from the valve means.

SUMMARY OF THE INVENTION

In one aspect of the invention there is provided a medical device forvessel occlusion, the medical device including an elongated body havinga distal end portion, a proximal end portion, and a lumen disposedtherethrough. The medical device further includes an inflatable balloondisposed at the distal end portion of the elongated body, the balloonbeing in fluid communication with the lumen, and an opening defined atthe proximal end portion of the elongated body, the opening being influid communication with the balloon via the lumen. A valve body ismoveably disposed at the proximal end portion of the elongated body; thevalve body being movable between a closed position and an open position.The valve body is configured to engage a surface of the elongated body,distal to the opening, to seal the opening when the valve body is in theclosed position.

In another aspect of the invention, there is provided a medical devicefor vessel occlusion. The medical device includes an elongated bodyhaving a distal end portion, a proximal end portion, and a lumendisposed therethrough. The medical device further includes an inflatableballoon disposed at the distal end portion of the elongated body, theballoon being in fluid communication with the lumen. An opening isdefined at the proximal end portion of the elongated body, the openingbeing in fluid communication with the balloon via the lumen. A valvebody is moveably disposed at the proximal end portion of the elongatedbody, the valve body being movable between a closed position and an openposition. The valve body is configured to engage an outer surface of theelongated body to seal the opening when the valve body is in the closedposition.

In another aspect of the present invention there is provided a medicaldevice for vessel occlusion, the medical device including an elongatedbody having a distal end portion, a proximal end portion, and a lumendisposed therethrough. The medical device further includes an inflatableballoon disposed at the distal end portion of the elongated body, theinflatable balloon being in fluid communication with the lumen. Anopening is defined at the proximal end portion of the elongated body,the opening being in fluid communication with the balloon via the lumen.A valve body is moveably disposed at the proximal end portion of theelongated body, the valve body being movable between a closed positionand an open position. The valve body is configured to engage an outersurface at the proximal end portion of the elongated body, distal to theopening, to seal the opening when the valve body is in the closedposition. The valve body includes a side wall having a cavity definedtherein to receive the proximal end portion of the elongated body, andan outer surface substantially flush with an outer surface of the distalend portion of the elongated body when in the closed position. At leastone of the valve body and the elongated body has a projection extendingtherefrom for mating engagement with the other body to preventinadvertent movement of the valve body at least when in the closedposition.

DETAILED DESCRIPTION OF THE DRAWINGS

The objects and advantages of the invention will become apparent fromthe following detailed description of preferred embodiments thereof inconnection with the accompanying drawings in which like numeralsdesignate like elements and in which:

FIG. 1 is a side view of the medical device according to the presentinvention;

FIG. 2 is a partial cross-sectional side view of one representativeembodiment of the distal tip of the medical device according to thepresent invention;

FIG. 2B is a partial cross-sectional side view of one representativeembodiment of a removable distal tip according to the present invention;

FIG. 3 is a partial cross-sectional side view of another representativeembodiment of the distal tip of the medical device according to thepresent invention;

FIG. 4 is a partial cross-sectional side view of yet anotherrepresentative embodiment of the distal tip of the medical deviceaccording to the present invention;

FIG. 5 is a partial cross-sectional side view of still anotherrepresentative embodiment of the distal tip of the medical deviceaccording to the present invention;

FIG. 6 is a partial cross-sectional side view of one representativeembodiment of the proximal end portion of the medical device accordingto the present invention;

FIG. 7 is a partial cross-sectional side view of another representativeembodiment of the proximal end portion of the medical device accordingto the present invention;

FIG. 8 is a partial cross-sectional side view of another representativealternative embodiment of the proximal end portion of the medical deviceaccording to the present invention;

FIG. 9 is a cross-sectional side view of a representative embodiment ofa valve body according to the present invention;

FIG. 10 is a cross-sectional side view of a representative alternativeembodiment of the valve body according to the present invention;

FIG. 11 is a partial cross-sectional side view of a representativeembodiment of the proximal end portion of the medical device accordingto the present invention illustrating the valve body disposedthereabout;

FIG. 12 is a partial cross-sectional side view of the proximal endportion of the medical device according to the present invention showingthe valve body in an opened position;

FIG. 13 is a partial cross-sectional side view of an alternativerepresentative embodiment of the proximal end portion of the medicaldevice according to the present invention illustrating the valve bodydisposed thereabout;

FIG. 14 is a partial cross-sectional side view of the alternativeembodiment of the proximal end portion of the medical device accordingto the present invention showing the valve body in an opened position;

FIG. 15 is a partial cross-sectional side view of another alternativeembodiment of the proximal end portion of the medical device accordingto the present invention illustrating the valve body disposedthereabout;

FIG. 16 is a partial cross-sectional side view of of the proximal endportion illustrating a plurality of apertures formed within the wall ofthe medical device;

FIG. 17 is a partial cross-sectional side view of of the proximal endportion illustrating a skive formed within the wall of the medicaldevice;

FIG. 18 is a partial cross-sectional side view of an alternativeembodiment of the proximal end portion of the medical device accordingto the present invention illustrating a plurality of elongated slotsformed within the wall of the medical device;

FIG. 19 is a partial cross-sectional side view of the alternativeembodiment of the proximal end of the medical device according to thepresent invention illustrating a skive formed within the proximal endportion of the medical device;

FIG. 20 is a partial side view of a representative alternativeembodiment of the proximal end of the medical device according to thepresent invention;

FIG. 21 is a cross-sectional end view of the alternative embodiment ofthe proximal end portion of the medical device shown in FIG. 20;

FIG. 22 is a cross-sectional end view of the alternative embodiment ofthe proximal end portion of the medical device shown in FIG. 20;

FIG. 23 is a partial side view of another representative alternativeembodiment of the proximal end portion of the medical device accordingto the present invention;

FIG. 24 is a partial cross-sectional side view of another representativealternative embodiment of the proximal end portion of the medical deviceaccording to the present invention;

FIG. 25 is a partial cross-sectional side view of another representativealternative embodiment of the proximal end portion of the medical deviceaccording to the present invention;

FIG. 26 is a partial cross-sectional top view of another representativealternative embodiment of the proximal end portion of the medical deviceaccording to the present invention;

FIG. 27 is a partial cross-sectional side view an alternative embodimentof the valve body of the medical device according to the presentinvention;

FIG. 28 is a partial cross-sectional top view of an alternativeembodiment of the medical device according to the present invention;

FIG. 29 is a partial cross-sectional side view of the alternativeembodiment of the medical device as shown in FIG. 28;

FIG. 30 is a cross-sectional end view taken about line A-A of FIG. 29,of the alternative embodiment of the medical device of FIG. 29;

FIG. 31 is a partial side view of the valve body according to FIG. 28;

FIG. 32 is a partial cross-sectional side view of the valve body of FIG.31 as disposed within the proximal end portion of the medical device ofFIG. 28; and

FIG. 33 is a partial cross-sectional side view of an alternativeembodiment of the proximal end portion and valve body in accordance withthe present invention.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

In accordance with the present invention there is shown and described amedical device for vessel occlusion. The medical device includes anelongated body having a distal end portion, a proximal end portion, anda lumen disposed therethrough. A balloon is disposed at the distal endportion of the elongated body, the balloon being in fluid communicationwith the lumen. An opening is defined at the proximal end portion of theelongated body, the opening being in fluid communication with theballoon via the lumen. A valve is disposed at the proximal end portionof the elongated body, the valve including a valve body movable betweena closed position and an open position. The valve body is configured toengage a surface of the elongated body, distal to the opening, to sealthe opening when the valve body is in the closed position.

Referring now to FIGS. 1, 2, and 11, there is shown a representativeembodiment of a medical device 100 according to the present invention.The medical device 100 includes an elongated body 105 having a proximalend portion 104 and a distal end portion 102 and at least one lumen 101disposed therethrough defining an inner cavity. An inflatable balloon120 is disposed proximate the distal end portion 102, wherein the innercavity of the balloon 120 is in fluid communication with the lumen 101of the medical device 100.

If desired, at least one radiopaque marker 108 may be disposed at thedistal end portion of the elongated body 105 proximate the balloon 120.Preferably, at least one radiopaque marker 108 is disposed within thedistal end of the cavity defined by the balloon, and if desired, atleast one proximal radiopaque marker 106 is disposed within the proximalend of the cavity defined by the balloon. The medical device 100 alsomay include a flexible tip 160. The flexible tip 160 may extend from thedistal end portion 102 of the medical device 100.

In accordance with the present invention, the medical device 100includes at its proximal end portion 104 a valve body 150, wherein thevalve body 150 is movable between a closed position and an openposition; the valve body configured to engage a surface of the elongatedbody to seal the opening when the valve body is in the closed position.The medical device 100 will be described in greater detail below.

The elongated body 105 of the medical device 100 may be constructed ofany suitable material including but not limited to polymide material,alloy materials, and metallic materials such as stainless steelhypodermic tubing which is available from MicroGroup® Inc., Medway, Md.Preferably the elongated body 105 of the medical device 100 isconstructed of a nickel titanium alloy known as Nitinol. Materials suchas these are available from various suppliers such as Memry Corp., MenloPark, Calif. US. The above materials should not be considered limitingin any manner, it is contemplated that the elongated body 105 may beconstructed of any bio-compatible material. For example, the elongatedbody may be constructed of a polymer such as polymide tubing from HVTechnologies, Inc. of Trenton, Ga. US. The elongated body 105 may bemanufactured using well known techniques such as swaging, machining,grinding, electropolishing, EDM, heat forming, extruding, or by anyother processes commonly used to shape and configure small metal orpolymer components. Additionally, the elongated body 105 may beconstructed from polypropylene or urethane by an extrusion process usingan extruder such as that available from Medical Extrusion Technologies,Inc. Murieta, Calif. US.

The elongated body 105 may be further coated with any of a variety ofmaterials to enhance performance if desired. For example possiblecoating materials include lubricious materials such as Teflon® availablefrom DuPont De Nemours, Wilmington, Del. US, and hydrophobic materialssuch as silicone lubricant dispersion PN 4097, available from AppliedSilicone Corp., Ventura, Calif. US, or a hydrophilic materials such ashydrogel available from Hydromer, Branchburg, N.J. US, or lubriciouscoatings such as those available from Hydro-Silk of Merritt Island,Fla., under the trade name TUA Systems.

The elongated body 105 may have any suitable cross-sectional shape,including elliptical, polygon, or prismatic, although a circularcross-section generally is preferred. The cross-sectional dimensiongenerally is between about 0.01 millimeters to about 1.0 millimeters,preferably between about 0.10 millimeters and about 0.50 millimeters,most preferably between about 0.250 millimeters and about 0.450millimeters. Furthermore the medical device 100 may have an overalllength between about 180 centimeters and 400 centimeters, preferablybetween about 250 centimeters and about 350 centimeters, more preferablythe medical device has a length between about 290 centimeters and about310 centimeters, and most preferably about 300 centimeters.

Referring now to FIG. 2 there is shown a partial cross-sectional sideview of the distal end portion 102 of the medical device 100. As shownin FIG. 2, a flexible tip 160 may extend from the distal end portion 102of the elongated body 105. A variety of distal tip configurations areknown an used in the art, each generally capable of performingparticular functions. For example, and as embodied herein, the flexibletip 160 is constructed of a solid inner core wire 162 of type 304stainless steel, wherein the solid core 162 is wrapped with abio-compatible wire 164. Examples of a bio-compatible wire 164 which maybe utilized include stainless steel, Nitinol, Titanium, Platinum,Iridium, and similar bio-compatible materials. In a preferred embodimentthe bio-compatible wire 164 is platinum wire. Platinum wire ispreferably used because platinum wire is visible under fluoroscopythereby enabling a surgeon to locate the flexible tip 160 within apatient's body in use. By utilizing a solid inner core 162 for theflexible tip 160, the distal tip may include a pre-formed curve 169 asshown in FIG. 2. The pre-formed curve 169 in addition to a blunt tip 167form an atramatic tip thereby allowing the medical device 100 to beinserted within a patient's vasculature. The pre-formed curve 169ensures that the blunt tip 167 does not pierce the vessel/artery ororgan through which the medical device 100 is being advanced. It shallbe understood that the pre-formed curve 169 remains sufficiently pliableand elastic whereby an interventional device may be advanced over theouter diameter of the medical device 100 such that the pre-formed curve169 will straighten and allow the medical device to pass over. Such tipdesigns are well known in the art.

As shown in FIG. 2, the proximal end 166 of the flexible tip 160 asembodied herein is adapted to be received within the lumen 101 of themedical device 100. The proximal end 166 of the flexible tip 160 may besecured within the lumen 101 through the use of a bio-compatibleadhesive, such as Locktite® 4014, or through mechanical fasteningmethods such as soldering or a friction fit. In a preferred embodiment,the distal end portion 102 of the elongated body 105 is deformed aboutthe diameter of the distal end 166 of the flexible tip 160, therebyforming a fluid tight seal between the lumen 101 and the flexible tip160.

In accordance with another embodiment of the invention, referring now toFIG. 2B there is shown an alternative embodiment of the flexible tip 160as described above. As shown in FIG. 2B, the flexible tip 160 may beconstructed in the same or similar manner as that described above,wherein like reference numerals have been utilized to denote similarfeatures. The flexible tip 160 of FIG. 2B further includes a proximalend 166, wherein the proximal end 166 is adapted to be detachablyreceived within the lumen 101 of the elongated body 105. In use, it isdesirable to pre-prime the medical device 100, that is to remove as muchair as possible from the lumen 101 as well as the chamber 123 defined bythe balloon 120. Typically this is done by drawing a vacuum within thelumen 101 and chamber 123 and allowing a bio-compatible fluid such assaline or contrast to fill the lumen 101 and chamber 123 of the medicaldevice 100. Although most air is removed from the system, removal of100% of the air typically may not be possible. By constructing themedical device 100 with a removable tip as shown in FIGS. 2B and 4, abio-compatible fluid may be flushed distally through the lumen 101 andthe chamber 123 thereby forcing air out of these spaces. After the airhas been forced through the medical device 100, the flexible tip 160 isattached to the distal end portion 102 of the elongated body 105,wherein the medical device 100 is ready for use.

As previously noted, an inflatable balloon is provided at the distal endportion of the medical device of the present invention. The balloon 120may be constructed of any suitable, flexible bio-compatible materialsdepending upon the intended function of the medical device 100. Theballoon may be inelastic, if desired, although generally elasticmaterials are preferred. Examples of materials of which the balloon 120may be formed are urethane, polyvinyl chloride, silicone or othersimilar materials which have good elastomeric properties. Preferably theballoon 120 is constructed of C-Flex, which is available fromConsolidated Polymer Technologies, Inc. of Largo, Fla., USA. The C-Flexmaterial allows for the formation of a balloon having very specificdurometers, thereby enabling the balloon to be specifically tuned to beresponsive to a pre-determined force. For example, if a pressure of oneatmosphere or about 14 psi is available to be applied to a balloon andit is desirable to inflate the balloon from a first diameter of 0.90millimeters to a second diameter of about 6 millimeters, the durometerof the C-Flex may be adjusted thereby allowing for a balloon to beformed which will expand from the first diameter to the second desireddiameter in response to the applied force.

As embodied herein, specifically with reference to FIGS. 1 and 2, theballoon 120 may be radially disposed at the distal end portion 102 ofthe elongated body 105, wherein the balloon 120 is in fluidcommunication with the lumen 101 of the elongated body 105 through atleast one aperture 107 formed within the wall of the elongated body 105.The aperture 107 may be formed having a generally cylindrical geometryor the aperture may be formed as an elongated slit within the wall ofthe elongated body 105. Furthermore, it is contemplated that theaperture 107 may be embodied having many different geometric shapes andthe examples above and those which are shown in the Figures are merelyexemplary.

Alternatively, the balloon 120 may be disposed asymmetrically upon onlya portion of the outer wall circumference if desired. Furthermore, ifdesired, the proximal end of the balloon 120 may be disposed about theextreme distal end of the elongated body 105 as shown in FIG. 3, and asfurther depicted by U.S. Pat. No. 5,807,330, to George P. Teitelbaum,entitled “Angioplasty Catheter,” the entirety of which is herebyincorporated by reference.

As shown in FIG. 3, the distal end 121 of the balloon 120 may beattached to a support member 180, wherein the support member 180 may bedisposed within the lumen 101 of the elongated body 105. The supportmember 180 may extend beyond the distal end 121 of the balloon 120, suchthat the distal end 182 of the support member 180 functions in themanner as described above with reference to the flexible tip 160.Inflation of the balloon 120 as shown in FIG. 3 is accomplished throughthe distal end portion 102 and lumen 101 of the elongated body 105.

As embodied in FIGS. 4 and 5, the balloon 120 may be disposed about aballoon support member 140, wherein the balloon support member 140 isadapted to be received within the lumen 101 of the elongated body 105 asshown, or about the outer surface of the elongated body 105. The balloon120 as shown in FIGS. 4 and 5 is similar to that shown and describedabove with reference to FIGS. 1-3, wherein like numerals designatesimilar features. As shown in FIGS. 4 and 5, the chamber 123 of theballoon is in fluid communication with the lumen 101 through an aperture107′ formed in the balloon support member 140, wherein the balloonsupport member may be constructed of the same material as that of theelongated body 105. Alternatively, the balloon support member may beconstructed of any one of the materials described above with referenceto the elongated body 105 and the balloon 120.

The balloon 120 may be integrally formed onto the elongated body 105adjacent to the distal end portion 102 of the elongated body 105 throughdip forming, spray forming, extrusion, heat forming, or similarmanufacturing processes. Preferably the balloon 120 is formedindependent of the elongated body 105 by employing one of or a pluralityof the processes above and then fixedly attached to the elongated body105. Prior to affixing the balloon 120 to the elongated body 105, anycoating applied to the elongated body 105 in the area where the balloon120 is to be affixed is first removed if necessary. The balloon 120 isthen positioned adjacent the distal end portion 102 such that theproximal end 124 and the distal end 122 of the balloon 120 extend beyondthe apertures 107 formed in the elongated body 105. The balloon 120 maybe fixedly attached to the elongated body with a bio-compatible adhesivesuch as Loctite® 4014. Heat shrink tubing 125 may be disposed about theproximal end 124 and the distal end 122 of the balloon to further affixthe balloon 121 to the elongated body 105.

As shown in FIGS. 2-5, a distal marker band 108 and a proximal markerband 106 may be disposed about the distal and proximal ends of theballoon 120, wherein the marker bands 106/108 may be constructed of abio-compatible material such as stainless steel, titanium, silver,platinum, gold, radiopaque plastics, or similar materials which may bereadily viewed under fluoroscopy. Preferably the marker bands 106/108are formed of gold. The marker bands 106/108 may be separate pieceswhich are fixedly attached to the diameter of the elongated bodyutilizing mechanical methods or adhesives. Preferably, the marker bandsare integrally formed upon the diameter of the elongated body throughthe use of spray coating, electroplating or similar methods which willdeposit the marker band material upon the elongated body. It shall beunderstood that additional marker bands may be disposed upon theelongated body 105 at any distance along the distal portion 102.

A bio-compatible adhesive 112 may be applied to the edges of the heatshrink tubing 125 as shown in FIGS. 2-5 in order to provide a smoothtransition surface between the heat shrink tubing 125 and the outerdiameter of the elongated body 105. An example of a bio-compatibleadhesive which may be utilize is Loctite® 3311, an ultra-violet curedadhesive.

It shall be understood that the balloon 120 may be disposed about theelongated body 105 at any distance along the distal end portion 102 ofthe elongated body 105, so long as the balloon is sealingly disposed influid communication with the lumen 101 of the elongated body 105.

As previously noted, and in accordance with the present invention themedical device also has a valve including a valve body configured to bemoveably disposed at the proximal end portion of the elongated body. Thevalve body is movable between a closed position and an open position,wherein the valve body is configured to engage a surface of theelongated body, to seal the opening when the valve body is in the closedposition.

The valve body may be configured to be movable in either an axial orradial direction. In a preferred embodiment, the valve body can be movedaxially between a sealed position and an opened position, and movedradially to engage or disengage a locking mechanism disposed upon theproximal end portion of the medical device.

The valve body when in a closed position is preferably flush with theouter diameter of the elongated body 105. By providing such a lowprofile valve body, interventional devices may be easily passed over themedical device. In an alternative embodiment, it is contemplated thatthe valve body may have a diameter greater than that of the elongatedbody 105, so long as the outer diameter of the valve body is not solarge as to inhibit the passage of interventional devices thereover.

Referring now to FIG. 9, there is shown a preferred embodiment of thevalve body 150 in accordance with one aspect of the present invention.The valve body 150 includes a proximal end portion 154 and a distal endportion 152, and a cavity 156 formed therebetween. The distal endportion 152 of the valve body is adapted to sealingly engage the outerdiameter of the elongated body as shown in FIG. 11.

The cavity 156 of the valve body 150 may further include a pliablecoating to aid in the sealing of the valve body to the elongated body105. The coating may be silicone, urethane, TFE. In a preferredembodiment the pliable coating is a parylene coating. The valve body 150may be constructed of a bio-compatible material such as titanium,stainless steel, polyurethane, polyvinyl chloride, Nitinol, or similarmaterials, wherein the valve body further has a closed proximal endportion 154, such as a plug 158 disposed within the lumen 151 of thevalve body 150. The plug 158 may be formed of the materials listedabove. In a preferred embodiment the plug 158 may be formed of solder,wherein a solder, such as that described above may be utilized to formthe plug 158.

Referring now to FIG. 10 there is shown another embodiment of the valvebody 150 in accordance with the present invention. The valve body 150shown in FIG. 10 may further include a beveled section 156, wherein thebeveled section 156 may be formed at an angle β between about 0 andabout 90 degrees, preferably between about 30 and about 60 degrees, morepreferably the bevel 156 is formed having an angle of about 45 degrees.The bevel 156 is adapted to receive the step 117, as shown in FIG. 11,wherein the step may be formed adjacent the proximal end portion 104 ofthe elongated body 105, wherein the bevel 156 and step 117 form a fluidtight seal between the valve body 150 and the elongated body 105.

In accordance with the present invention, referring now to FIGS. 6, 9,and 11 there are shown partial cross-sectional side views of a firstrepresentative embodiment of the medical device 100. The proximal endportion 104 of the medical device 100 is shown in FIGS. 6, 9, and 11.FIGS. 9 and 11 illustrate a first representative embodiment of the valvebody 150, wherein as shown in FIG. 11, the valve body 150 can bedisposed about the proximal end portion 104 of the elongated body 105.The valve body 150 includes an elongated body having a proximal endportion 154 and a distal end portion 152, wherein the distal end portion152 is adapted to sealingly receive the elongated body 105 of themedical device 100, and the proximal end portion has a closed or blindend 158. As embodied herein, the valve body 150 therefore is movedaxially between an open position and a closed position as described ingreater detail below.

The valve body may be constructed of any suitable bio-compatiblematerial such as titanium, Nitinol, polymide, and other bio-compatibleplastics. In a preferred embodiment the valve body is constructed of astainless steel tube, wherein the proximal end 154 of the tube is sealedwith a plug 158. The plug 158 may be constructed of a bio-compatiblematerial such as titanium, Nitinol, stainless steel, nylon, delrin, andother similar materials. In a preferred embodiment the plug 158 isconstructed of solder available from Kester of Des Plains, Ill., whereinthe solder is preferably lead-free. It is further contemplated that thevalve body may be constructed of a unitary body wherein the valve bodymay be injection molded and being constructed of plastics or metals.

The valve body 150 defines a cavity 151 therein to receive the outerdiameter of the elongated body 105. If cylindrical in shape, the valvebody may have an inner diameter between about 0.10 millimeters and about2.0 millimeters, preferably between about 0.25 millimeters and about 1.0millimeters and most preferably between about 0.300 millimeters andabout 0.500 millimeters. The valve body further has a wall thicknessbetween about 0.001 millimeters and about 0.10 millimeters, preferablybetween about 0.025 millimeters and about 0.05 millimeters, mostpreferably between about. 0.03 millimeters and about 0.04 millimeters.

In accordance with the present invention, the elongated body 105 of themedical device may include a reduced cross-sectional dimension at theproximal end portion 104 to enhance sealing properties and to create alow profile valve configuration, as shown in FIGS. 6 and 11. Forexample, with a circular cross-sectional profile, a step 117 provides atransition between the reduced diameter area 115 and the diameter of theelongated body 105. The step 117 may be formed by grinding, molding,swaging, extruding, or other known techniques, and may be configured atany of a variety of angles, although the preferred angle α is betweenabout 0 and about 90 degrees, preferably between about 30 and about 60degrees and more preferably the angle is about 45 degrees. In thismanner, the outer surface of the valve body is substantially flush withthe outer surface of the elongated body 105 distal to the step 117. Itis further contemplated that the step 117 may be formed having a convexor concave radius (not shown). That is instead of being formed as alinear transition between the two diameters, the step 117 may form agradual radius between the two diameters, the gradual radius embodied aseither convex, concave or a combination thereof.

If desired, the proximal end portion 104 of the elongated body 105 mayhave a closed or blind end, such as by providing a plug 103 disposed toseal the lumen 101 as shown in FIG. 6. The plug may be constructed of abio-compatible material such as titanium, stainless steel, Nitinol,delrin, nylon, or similar materials. The plug 103 embodied herein isaffixed within the lumen 101 of the elongated body with a bio-compatibleadhesive which will adhere to the plug 103 and the inner wall of thelumen 101. In a preferred embodiment, the plug 103 is formed of soldersuch as that described above with regard to the valve body 150.Alternatively, the plug 103 is not necessary because the distal end 152of the valve body 150 sealingly contacts the outer diameter of theelongated body 105 thereby creating hemostasis within the medical device100. It shall be understood that if the plug 103 is not disposed withinthe lumen 101 of the elongated body 105, the valve body 150 must includethe plug 158 in order to form a fluid tight seal within the elongatedbody 105.

Referring now to FIGS. 11 and 12 there is shown the medical device 100in accordance with one aspect of the present invention in use. As shownin FIG. 11, the valve body 150 is disposed upon the proximal end portion104 of the elongated body 105, wherein the valve body is in a closedposition. The distal end 152 of the valve body forms a fluid tight sealwith the step 117 of the elongated body 105. The fluid tight seal may beformed through an interference fit between the distal tip 152 of thevalve body and the step 117 or altertnatively, as described herein theinner diameter of the valve body may include a parylene coating forenhanced sealing properties. Referring now to FIG. 12 there is shown thevalve body 150 in an open configuration. Wherein, when the valve body150 is in an open configuration, inflation fluid may be introduced intothe lumen 101 of the elongated body 105 thereby inflating the balloon120 of the distal tip portion 102. Inflation fluid may be introduced ina manner such as that disclosed by Teitlebaum, U.S. Pat. No. 5,807,330.Alternatively, inflation fluid may be withdrawn from the lumen 101,thereby deflating the balloon 120. As shown in FIGS. 11 and 12, thevalve body 150 may be selectively opened and closed in order to controlthe inflation and deflation of the balloon 120. To move the valve bodybetween an opened and closed position as shown an axial force or aradial force or a combination thereof may be applied to either or boththe valve body 150 or the elongated body 105. Additionally, the valvebody 150 only need be moved between about 0.005 inches and about 1.0inches, preferably between about 0.02 inches and about 0.75 inches, mostpreferably between about 0.05 inches and about 0.25 inches.

Another alternative embodiment in accordance with the present inventionis illustrated in FIG. 33, wherein there is shown a medical device 100having a valve body 150 disposed upon the proximal end portion 104 ofthe elongated body, wherein the plug 158′ of the valve body forms afluid tight seal with the very proximal end 137 of the elongated body105. The plug 158′ may further include a pliable coating as thosedescribed above in order to effectuate a better seal with the proximalend 137 of the elongated body 105. Furthermore, frictional interferencebetween the chamber 156 of the valve body and the outer diameter of theelongated body 150 act to retain the valve body 150 upon the proximalend portion 104 of the elongated body 105. It shall be understood thatthe medical device 100 embodied and described with reference to FIG. 33may be adapted to include any other feature described herein in relationto other embodiments of the medical device 100.

Referring now to FIGS. 7, 13-14, 18, and 19 there is shown analternative representative embodiment of the reduced diameter areaaccording to the present invention. As shown in FIGS. 7, 13-14, 18, and19, the reduced diameter area may include a plurality of steps, whereinthe first step 117 transitions the outer diameter of the elongated body105 to a first reduced diameter section 115 as described above. A secondstep 118 may be disposed proximal to the first step 117, wherein thesecond step 118 provides a transition between the first reduced diameterportion 115 and a second reduced diameter portion 116.

The second step 118 may be formed at an angle between about 0 and about90 degrees, preferably between about 30 and about 60 degrees, morepreferably between about 40 and about 50 degrees.

As shown in FIGS. 13 and 14, the second step 118 can provide improvedinflation and deflation of the balloon when the valve sleeve 150 ismoved proximally into an opened position. This is because, as the valvebody is moved from a closed position to an opened position, the valvebody 150 does not have to be moved past the openings 113 formed in thewall of the elongated body 105. That is, once the distal end 152 of thevalve body 150 passes proximal the second step 118 as shown in FIG. 14,a fluid flow path is formed between the second reduced diameter portionand the cavity 151 of the valve body 150. Indeed, by providing such aflow path, the extreme proximal end of the elongated body as shown inFIGS. 13 and 14, can be used to define an opening for inflation of theballoon such that additional openings need not be provided in the wallof the elongated body 105.

Referring now to FIGS. 8 and 15 there is shown yet another alternativeembodiment of the proximal end portion 104 of the medical device 100 inaccordance with the present invention. As shown in FIGS. 8 and 15, theproximal end portion 104 of the medical device 100 may include taperedsection 515, which can be formed by known techniques, such as grinding,milling, EDM, laser cutting, or swagging. The embodiment herein definesa constant angle of between about 0 and about 45 degrees, preferablybetween about 0 and about 10 degrees, more preferably between about 0.5and about 3 degrees. As shown in FIG. 15 a valve body 150 is disposedabout the tapered section 515, wherein the distal end 152 of the valvebody contacts the outer surface of the elongated body 105 therebysealing the openings 113 when in a closed position. The valve body 150may be moved axially, whereby an annular space is created about thedistal end 152 of the valve body 150 and the tapering outer diameter ofthe elongated body 105, thereby allowing for fluid to flow from theannular space into the lumen 101 and the chamber 123 of the balloon.

In accordance with the present invention an opening is provided at theproximal end portion 104 of the elongated body 105, the opening being influid communication with the balloon 120 via the lumen 101 of theelongated body 105, wherein the opening may be embodied in a variety ofconfigurations. As previously noted, the opening may be defined as theextreme proximal end of the elongated body. Alternatively, and asembodied herein, the opening may include at least one opening 113disposed through the wall of the elongated body 105 at the proximal endportion 104 thereof. Preferably, and when the proximal end portion 104is provided with an area of reduced cross-section, the opening islocated within the reduced diameter area 115 of the proximal end portion104 of the elongated body 105.

In accordance with the present invention, the opening 113 may be formedin a variety of manners, some of which are illustrated in FIGS. 6-8, and11-32. As shown in FIGS. 6-8 and 11-32, a plurality of openings may beformed through the wall of the reduced diameter sections 115 and 116,wherein the openings are disposed along the proximal end portion 104 ofthe elongated body 105. The openings 113 may be formed within the wallof the elongated body utilizing manufacturing processes such as laserdrilling, EDM, drilling, milling, electrochemical milling, and othersimilar procedures that will produce an opening through the wall of theelongated body 105.

Referring now to FIGS. 16 and 18, there is shown a first alternativeembodiment of the opening 213 in accordance with the present invention,wherein like numerals denote similar features as described above withreference to the medical device 100 of the present invention. Theopening 213 may be embodied in the form of at least one axiallyextending slit formed within the wall of the reduced diameter portion115 or second reduced diameter portion 116.

Referring now to FIGS. 17, 19, and 29 there is shown a secondalternative embodiment of the opening 313 in accordance with the presentinvention. The opening 313 may be embodied as a skive within the wall ofthe reduce diameter portion 115 or second reduced diameter portion 116.The skive may be formed within the wall of the elongated body 105 bypassing a grinding wheel over the portion of the elongated body wherethe skive 313 is to be formed.

In accordance with the invention, there are provided additionalalternative embodiments in accordance with the medical device of thepresent invention. As previously discussed, the medical device includesa proximal end portion and a valve body disposed thereon, wherein thevalve body is movable between an open position and a closed position, ina closed position the valve body sealingly engages the outer wall of theelongated body. In an open position the valve body allows for theinflation or deflation of the balloon as previously discussed.

Referring now to FIG. 24, the elongated body 105 and the valve body 450includes each of the elements described above and illustrated in FIG.11. Additionally, the elongated body 105 includes a slot 413 formedwithin the wall of the elongated body 105 wherein the slot 413 isaxially aligned with the elongated body 105. The slot 413 may be formedpartially into the outer wall, such as by a groove or dimple, or extendentirely through the wall of the elongated body 105 as an opening. Thevalve body 450 is disposed about the proximal end portion 104 of theelongated body 105 in the manner as described above. The valve body 450may further include a protrusion 455 extending into the cavity 456 ofthe valve body. The protrusion 455 is slidably received within the slot413 of the elongated body 105. The protrusion 455 therefore may retainthe valve body 450 upon the proximal end 104 of the elongated body 105,and limit the proximal movement of the valve body. The protrusion 455also may further provide tactile feedback to a user indicating whetherthe valve body is in an opened or closed configuration. The protrusionmay be formed as a separate body attached to the valve body 450, or theprotrusion may be formed integral with the valve body 450.Alternatively, the reduced diameter section may include a protrusion,either integrally formed therewith or fixedly attached thereto and thevalve body may include a slot or groove adapted to receive theprotrusion of the reduced diameter section.

Referring now to FIGS. 20-22, there is shown an alternative embodimentof the valve body 550 and reduced diameter portion 515. The reduceddiameter portion 515 further includes a groove 519, formed in the wallof the elongated body 105. The groove 519 may be formed in the wall ofthe elongated body by machining, grinding, EDM milling, or similarmanufacturing processes. Alternatively, the groove 519 may be formed bydeforming the wall of the elongated body as shown in FIG. 30. The valvebody 550 includes a pin 555 or similar protrusion extending into thecavity 556. When the valve body 550 is disposed about the reducediameter portion 515, the pin 555 is received within the groove 519,wherein the groove 519 guides the pin 555 during translation of thevalve body 550 between an opened position and a closed position. Thegroove 519 may be axially aligned with the lumen 101 of the elongatedbody 105 as shown in FIGS. 20-22, or extend helically to inducerotational movement of the valve body during displacement.Alternatively, the groove 519′ may be both axially and radially alignedwith the lumen 101 of the elongated body 105 as shown in FIG. 23. Byhaving a groove 519′ that is both axially and radially aligned requiresthat the valve body 550 be rotationally translated first and thenaxially translated in order to open the seal between the valve body andthe elongated body. This greatly reduces or eliminates the possibilityof the valve body 550 from being accidentally opened.

Referring now to FIGS. 25-27 there is shown another alternativeembodiment in accordance with the medical device of the presentinvention. Referring now to FIG. 25 there is shown a partialcross-sectional side view of an alternative embodiment of the proximalend portion 904 of an elongated body 905, wherein the proximal endportion 904 further includes a pin 990 disposed axially through thewalls and lumen 901 of the proximal end portion 904. Betterunderstanding of the location of the pin 990 may be understood withreference to the cross-sectional top view of FIG. 26 illustrating thepin 990 being disposed through the proximal end portion 904 of theelongated body 905 perpendicular to the top view. Referring now to FIG.27, there is shown a corresponding embodiment of a valve body 950,wherein the valve body 950 includes a track 930. The track provides aguide for positioning the valve body 950 when the groove 930 engages thepin 990. A step 917 forms a tapered portion on the proximal end of thevalve body 950, wherein then the valve body 990 is inserted within thelumen 901 of the elongated body 905 the tapered portion engages theinner diameter of the proximal end portion of the elongated bodytherefore forming a fluid tight seal. In order to effectuate a sealbetween the tapered portion of the valve body 950 and the lumen 901 ofthe proximal end portion 904 of the elongated body 905 involves twomovements, one axial movement and a second rotational force. The secondrotational force requires that a deliberate action on the part of anoperator to disengage the seal once the seal has been formed. The secondaction of the rotational force also makes it more difficult for theoperator to inadvertently open the port by merely pulling axially on thevalve body 950. Alternatively, the pin 990 can extend beyond the outersurface of the elongated body, and the valve body can be configured tobe disposed about the outside of the proximal end portion of theelongated body with the groove being formed on an inside surface of thevalve body.

The track 930 may be formed within the outer surface of the valve body950 utilizing any of the processes as described above.

Referring now to FIGS. 28-32, there is shown an additional alternativeembodiment in accordance with the present invention. Referring to FIG.28 there is shown partial cross-sectional top view of a medical device800, wherein the medical device 800 includes an elongated body 805having a distal portion (not shown) and a proximal end portion 804,wherein the proximal end portion 804 includes at least one groove formedtherein as shown in FIG. 30. The medical device 800 further includes anopening 815 disposed adjacent to the proximal end portion 804 of theelongated body 805. As shown in FIG. 29, the opening 815 may be formedas a skive. Although the opening 815 is shown to be embodied as a skivethis should not be considered limiting in any manner, it is contemplatedthat any of the openings described herein may be utilized in addition toor as an alternative to the skive. The skive 815 may be formed utilizingany of the methods described above.

Referring now to FIG. 31 there is shown a valve body 850, wherein thevalve body includes a proximal end portion 854 and a distal end portion852 and a tapered portion 817 disposed therebetween.

As shown in FIGS. 28 and 32, the valve body 850 is disposed proximallywithin the lumen 801 of the medical device 800 when in the openedposition, To close the medical device, the valve body 850 is advanceddistally within the lumen 801 of the elongated body 805 until thetapered section 817 passes the distal portion of the opening 815 andengages the inner surface of the proximal end portion of the elongatedmember. If desired, a groove and protrusion configuration also can beprovided. In this manner, the valve body 850 is then rotated to lock thevalve body 850 into place. Therefore, as described above with regard toFIGS. 25-27 the valve body cannot be inadvertently removed from theinner lumen 801 of the elongated body 805 without first applying arotational force to the valve body 850.

The alternative embodiments of the medical device 900 and 800illustrated in FIGS. 25-32 may be constructed according to the aspectsand methods described above wherein the same materials may also beutilized. In addition, the valve bodies 950 and 850 may further includea coating such as that described above with regard to FIGS. 9 and 10 andthe valve body 150 disclosed therein to effectuate a better seal uponthe medical device 900 and 800.

The groove 830 formed within the proximal end portion 804 of theelongated body 805 may be formed utilizing any of the methods describedabove with reference to the medical device 100. Preferably the groove830 is formed within the side wall of the elongated body through acrimping or dimpling process.

The medical device 100 descried and illustrated herein may be utilizedin vascular interventional procedures such as angioplasty or stenting.In such procedures, an access site to the patient's vasculature isformed, typically within the patient's femoral artery. The patient issystematically heparinized during the procedure. Via the femoral arteryapproach, a long 9-French access sheath is inserted through the commonfemoral artery and is advanced into a desired position. Once access hasbeen established, the medical device 100 is inserted into the patient'svasculature.

Through the use of fluoroscopy and the soft steerable flexible tip 160of the medical device 100, the medical device 100 is placed adjacent asite in which a medical procedure is to be performed. Placement of themedical device 100 can be confirmed by fluoroscopy confirmation of theplurality of marker bands 108/106 disposed upon the distal end portion102 of the medical device 100. The balloon 120 may then be inflated byopening the valve body 150, wherein inflation fluid may be introducedthrough the openings 113 in the proximal end portion of the medicaldevice 100, such as described by Teitelbaum, U.S. Pat. No. 5,807,330.After the balloon 120 is inflated to a sufficient diameter, the valvebody 150 may be moved into a closed position thereby forming a fluidtight seal. The balloon 120 remains inflated, while the source ofinflation fluid may then be removed from the proximal end portion 104 ofthe medical device 100. An example of a device which may be utilized tointroduce inflation fluid is a Tuohy-Borst device, wherein theTuohy-Borst device may be removed from the medical device 100 asdesired. Alternatively, a removable inflator box may be provided, whichis capable of creating a sealed chamber about the proximal end portionof the elongated member, and allowing selective movement of the valvebody between the open and closed positions as known in the art. Examplesof inflation fluid which may be utilized are saline or carbon dioxide,preferably contrast fluid is utilized as the inflation fluid therebyenabling visualization of the balloon 120 under fluoroscopy.

At this point a balloon angioplasty catheter may be inserted over themedical device 100, wherein the balloon 120 acts to anchor the medicaldevice 100 within the patient's vasculature as well as to occlude thevessel. If desired, the medical device 100 may be utilized to pre-dilatethe stenosis within the vessel is the appropriate balloon constructionis provided. Alternatively, an angioplasty balloon catheter, and/or astent delivery device and/or other known interventional devices may beadvanced over the medical device 100 to the site to perform a desiredprocedure as is known in the art. Debris thus created by theinterventional device during an interventional procedure can be removedthrough an aspiration catheter which may be advanced over the medicaldevice 100 as described below.

Following the interventional procedure, the interventional device isremoved from the medical device 100 and an aspiration catheter may beadvanced over the medical device 100 to a position near the site.Vigorous flushing of the site may be performed by injecting a largevolume of saline into the site. Alternatively or additionally, debrismay be removed distal the lesion through a lumen of an aspirationcatheter by selectively positioning the aspiration catheter within thesite.

After debris has been removed from the site and the aspiration catheteris removed from the medical device 100, the valve body 150 is moved froma closed position to an open position wherein the inflation fluid may beremoved, thereby deflating the balloon 120 of the medical device 100. Atthis time the medical device 100 may be withdrawn from the patient'svasculature. Alternatively, the medical device 100 may remain aspositioned, wherein additional interventional procedures may beperformed at the site, wherein the site may be aspirated as describedfollowing any interventional procedure. The medical device 100 mayremain as positioned as long as there is a need to perform additionalinterventional procedures.

Although the present invention has been described in considerable detailwith reference to certain preferred embodiments, it is contemplated thatone skilled in the art may make modifications to the device hereinwithout departing from the scope of the invention. Therefore, the scopeof the amended claims should not be considered limited to theembodiments described herein.

1. A medical device for vessel occlusion, the medical device comprising:an elongated body having a distal end portion, a proximal end portion,and a lumen disposed therethrough; an balloon disposed at the distal endportion of the elongated body, the balloon in fluid communication withthe lumen; an opening defined at the proximal end portion of theelongated body, the opening being in fluid communication with theballoon via the lumen; and a valve body moveably disposed at theporixmal end portion of the elongated body, the valve body movablebetween a closed position and an open position, the valve bodyconfigured to engage a surface of the elongated body, distal to theopening, to seal the opening when the valve body is in the closedposition. 2-20. (canceled)